This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.

Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area

Perineal skin closure cosmesis

Patient satisfaction

Estimated Enrollment:

118

Study Start Date:

April 2005

Estimated Study Completion Date:

January 2006

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient is at least 18 years of age.

Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.

Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.

Patient has signed the informed consent form.

Exclusion Criteria:

Patient has peripheral vascular disease.

Patient has insulin dependent diabetes mellitus.

Patient has a blood clotting disorder that requires therapy.

Patient has a personal or family history of keloid formation or hypertrophy.

Patient has a known allergy to cyanoacrylates or formaldehyde.

Patient has impaired wound healing by history. Patient is a chronic steroid user.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196508